The Role of C-11 Choline PET in Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The investigators determine the target number as 54 patients based on the following reasons:

(a) The bony metastasis rate for the high risk prostate cancer patients with PSA from 20 to 99.9 ng/ml was 21% (166/767 cases in a systemic review) [8]; the estimated sample size would be 47 under the condition of 20% more distant metastasis cases were identified by the PET/MRI scan using the 90% power, significance level of 0.05 and one sample proportion test. Assuming a dropout rate of 10%, the final ideal sample size is 52 patients. (b) The newly diagnostic number for the high risk prostate cancer patients in our hospital annually is ~70, about 6 patients a month. It is clinically feasible to recruit 3 patients a month until 18 months since the study begin. The study could be completed in 2 years with 54 cases

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: Choline

Criteria

Inclusion Criteria:

1. Clinically suspicious and/or pathology-proved high risk group prostate cancer patients (PSA > 20 ng/mL, or Gleason score 8-10, or clinical stage >T2c)

2. Age equals or more than 20 years old

3. Willing to sign the informed consent

Exclusion Criteria:

1. Patients with a concomitant or previous malignancy history

2. Unable to tolerate MR or PET/CT scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears, hip prosthesis), claustrophobia, unable to lie still

3. Unable to give informed consent

4. Previous allergy to carbon-labelled radionuclide